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Nicolas STANOWSKI

SAINT PRIEST Cedex

En résumé

Mes compétences :
Audit
Business
Business development
Pharmaceutical Industry
Quality
Quality Audit
Teamwork

Entreprises

  • MYLAN - Global Quality Auditor

    SAINT PRIEST Cedex 2010 - maintenant Global Quality Auditor for MYLAN, located in Lyon (FRANCE). Perform objective audits of internal GXP systems and external businesses for Mylan management in order to accurately depict the status of compliance and to foster improvements based on current GXP references and interpretations. Prepare all associated documentation including audit plans and audit reports. Provide guidance and support in the development of corrective actions based on GXP principles and current industry standards. Track and monitor audit responses and the implementation of corrective actions.
  • MERCK - Raw Material Project Leader

    Lyon 2003 - 2009 API Officer, Department “Regulatory & Development” in MYLAN France (formerly MERCK GENERIQUES France) (LYON 69). Technical, Regulatory follow-up and Sourcing of a range of 180 different active ingredients integrated in the formula of the MYLAN medicinal products. Assessment of DMF and analytical expertise, development follow-up of new synthesis processes for the pharmaceutical active substances: follow-up of the analytical and regulatory accreditations of the new sources; regulatory monitoring of the registered active ingredients. Audit of ASM following GMP rules and ICH-Q7. From June 2008, attached to Pharmaceutical development of the Business Unit Hospital Product.
  • CEVA Santé Animale - R&D trainee

    2002 - 2002 R&D: CEVA SANTE Animale (LIBOURNE 33). Engaged in the pharmaceutical development of an anti-infective agent (part IIB to IIF). Industrial process optimization of FP, monitoring of stability tests. Optimization and validation of the analytical test procedures (Active Ingredient and impurities).
  • CREAPHARM - R&D trainee

    LE HAILLAN 2001 - 2001 University of Bordeaux 33. Multi-ingredients UV spectroscopy: Development and validation of the analytical method for the monitoring of dissolution tablets. HPLC, GC: CREAPHARM (BORDEAUX 33). Development and validation of HPLC, GC methods for the release of finished dosage forms.
  • E.N.S.C.T - Chemistry trainee

    1998 - 1998 E.N.S.C.T agro-industrial chemistry Laboratory (TOULOUSE 31). Work carried out for the development of a new process of chlorination (monitoring of kinetic and racemic reactions).

Formations

  • Faculty Of Pharmacy (Bordeaux)

    Bordeaux 2002 - 2002 DESS: Analytical methodologies applied to the Health medicinal products.

    Master Degree
  • Le Havre University (Le Havre)

    Le Havre 2000 - 2001 Master of Sciences & Technologies - Optional field: organic synthesis and structure-activity relationship.
  • University Of Poitiers

    Poitiers 1999 - 1999 Bachelor Degree - Diploma (Licence) of general Chemistry.
  • IUT De POITIERS

    Poitiers 1996 - 1998 D.U.T of chemistry (Technical University Diploma)

    Associate Degree

Réseau

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